Clinical Study to Evaluate Tolerability and Safety of ARK-E021 Foam and to Monitor Clinical Effect in Acne Vulgaris Patients

NCT01494285 | Completed Phase 1

• 1 other identifier: MA1001
• Study Type: interventional
• Target: 157
• Locations: 1 country
• Sites: 3

Brief Summary

This is a multicenter, randomized, double-blind, placebo-controlled, 3-arm, parallel-group, ambulatory safety and efficacy study of ARK-E021 topical foam of 5% and 10% in subjects with mild to moderate acne vulgaris.

Conditions

Acne Vulgaris

Keywords

Acne Vulgaris; Topical; Foam

Outcome Measures

Primary Outcomes (2)

• To evaluate the safety and tolerability of ARK-E021 topical foam in subjects with acne vulgaris.

  Subject safety will be assessed following treatment using measurements of the following variables: * Physical examination. * Vital Signs (HR, BP, Body temperature). * Adverse events recording. * Concomitant medications.

  Baseline through week 16.

• To evaluate the efficacy of ARK-E021 topical foam in subjects with acne vulgaris.

  Subject efficacy will be assessed following treatment using measurements of the following variables: * Lesion count (inflammatory/non inflammatory and total). * Investigator global assessment (IGA; grade 0-4). * Lesion documentation by photographs (optional).

  Baseline through week 16.

Study Arms (3)

ARK-E021 5% foam

EXPERIMENTAL

Drug: ARK-E021 5%

ARK-E021 10% foam

EXPERIMENTAL

Drug: ARK-E021 10%

Placebo foam

PLACEBO COMPARATOR

Drug: Placebo

Interventions

ARK-E021 5% DRUG

Topically applied once daily at bedtime

Also known as: Not yet marketed

ARK-E021 5% foam

ARK-E021 10% DRUG

Topically applied once daily at bedtime

Also known as: Not yet marketed

ARK-E021 10% foam

Placebo DRUG

Topically applied once daily at bedtime

Also known as: Not marketed

Placebo foam

Eligibility Criteria

• Age: 12 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Patient is male or female between the ages of 12 to 40.
• A clinical diagnosis of acne vulgaris with facial involvement.
• Minimum of 15 inflammatory lesions on the face (papules and/ or pustules)but not more than 40.
• Existence of non-inflammatory lesions on the face (opened and/or closed comedones).
• A score of ≥2 (moderate) on the investigator's global assessment scale.
• Use of non oral contraceptives in female of childbearing potential during the study.
• No known medical conditions that, in the Investigator's opinion could interfere with study participation.
• Patient is willing and able to comply with all the requirement of the study protocol.
• Patient is willing and able to give written informed consent prior to participation in the study.

You may not qualify if:

• Acne conglobata, acne fulminans, secondary acne (chloracne, drug induced acne), or severe acne requiring systemic treatment.
• One or more active nodule/cyst acne on the face (inactive lesions allowed).
• Excessive facial hair (e.g. beards, sideburns, moustaches, etc.) that would interfere with diagnosis or assessment of acne vulgaris.
• Participation in another investigational drug trial within 30 days prior to study entry.
• Concomitant medication:
• Use of systemic steroids, systemic antibiotics, systemic treatment for acne vulgaris, systemic anti-inflammatory agents within 4 weeks prior to baseline or during the study.
• Use of topical steroids, topical antibiotics, topical treatment for acne vulgaris, topical anti-inflammatory agents within 2 weeks prior to baseline or during the study.
• Treatment for acne with isotretinoin or isotretinoin derivatives within 12 months prior to study entry.

Sponsors & Collaborators

• M. Arkin 1999 Ltd.: lead
• Vyne Therapeutics Inc.: collaborator

Study Sites (3)

HaEmek Medical Center

Afula, Israel

Location

Meir Medical Center

Kfar Saba, Israel

Location

Souraski Medical Center

Tel Aviv, Israel

Location

MeSH Terms

Conditions

Acne Vulgaris

Condition Hierarchy (Ancestors)

Acneiform Eruptions; Skin Diseases; Skin and Connective Tissue Diseases; Sebaceous Gland Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 15, 2011
• First Posted: December 16, 2011
• Study Start: June 1, 2012
• Primary Completion: October 1, 2013
• Study Completion: October 1, 2013
• Last Updated: December 3, 2013

Record last verified: 2013-12

Locations

IL (3)